Subject: Sprycel 1782-A SGM P2023
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Newly diagnosed adults with Philadelphia chromosome-
positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
2. Adults with chronic, accelerated, or myeloid or lymphoid
blast phase Ph+ CML with resistance or intolerance to
prior therapy including imatinib
3. Adults with Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL) with resistance or
intolerance to prior therapy
4. Pediatric patients 1 year of age and older with Ph+ CML in
chronic phase
5. Pediatric patients 1 year of age and older with newly
diagnosed Ph+ ALL in combination with chemotherapy
B. Compendial Uses
1. Primary treatment of advanced phase CML (accelerated
phase or blast phase)
2. Follow-up therapy for CML patients after hematopoietic
stem cell transplant (HSCT)
3. Ph+ B-cell acute lymphoblastic leukemia or
lymphoblastic lymphoma (Ph+ B-ALL/LL)
4. Maintenance therapy for Ph+ B-ALL/LL patients after
HSCT
5. Relapsed or refractory Ph+ B-ALL/LL
6. Relapsed or refractory T-cell ALL/LL with ABL-class
translocation
7. Induction or consolidation therapy for Ph-like B-ALL/LL
with ABL-class kinase fusion
8. Consolidation therapy for Ph-like B-ALL/LL and CRLF2-
with ABL-class kinase fusion
9. Metastatic and widespread chondrosarcoma
10. Recurrent chordoma
11. Gastrointestinal stromal tumor (GIST)
12. Myeloid/lymphoid neoplasms with eosinophilia and ABL1
rearrangement in chronic or blast phase
13. Cutaneous Melanoma
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
The following information is necessary to initiate the prior
authorization review:
A. For treatment of CML or Ph+ ALL/LL: results of cytogenetic
and/or molecular testing for detection of the Ph chromosome
or the BCR::ABL gene
B. For treatment of Ph-like B-ALL/LL: results of cytogenetic
and/or molecular testing confirming ABL-class kinase fusion
C. For treatment of T-cell ALL/LL: results of cytogenetic and/or
molecular testing confirming ABL-class translocation
D. For members requesting initiation of therapy with the
requested medication for treatment of CML or ALL/LL after
experiencing resistance to prior tyrosine kinase inhibitor
(TKI) therapy: results of BCR::ABL1 mutation testing for
T315I/A, F317L/V/I/C, and V299L mutations
E. For treatment of GIST: PDGFRA exon 18 mutation testing
(where applicable)
F. For members requesting initiation of therapy with the
requested medication for treatment of myeloid and/or
lymphoid neoplasms with eosinophilia: results of testing or
analysis confirming ABL1 rearrangement
G. For treatment of melanoma: results of molecular testing or
analysis confirming c-KIT activating mutations
III. CRITERIA FOR INITIAL APPROVAL
A. Chronic Myeloid Leukemia (CML)
Authorization of 7 months may be granted for treatment of
CML that has been confirmed by detection of the Ph
chromosome or BCR::ABL gene by cytogenetic and/or
molecular testing when any of the following criteria are met:
1. Member has not received prior therapy with a TKI (e.g.,
bosutinib, imatinib, nilotinib, ponatinib)
2. Member experienced toxicity or intolerance to prior
therapy with a TKI
3. Member experienced resistance to prior therapy with a
TKI and results of BCR::ABL1 mutational testing are
negative for all of the following: T315I/A, F317L/V/I/C,
and V299L
4. Member has received HSCT for CML and results of
BCR::ABL1 mutational testing are negative for all of the
following: T315I/A, F317L/V/I/C, and V299L
B. Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic
Lymphoma (LL)
1. Authorization of 12 months may be granted for treatment
of ALL/LL when both of the following criteria are met:
i. The member has any of the following:
a. Ph+ ALL/LL that has been confirmed by detection
of the Ph chromosome or BCR::ABL gene by
cytogenetic and/or molecular testing
b. Ph-like B-ALL/LL with ABL-class kinase fusion that
has been confirmed by cytogenetic and/or
molecular testing
c. T-cell ALL/LL with ABL-class translocation that has
been confirmed by cytogenetic and/or molecular
testing and the disease is relapsed or refractory
ii. The member meets any of the following:
a. Member has not received prior therapy with a TKI
(e.g., bosutinib, imatinib, nilotinib, ponatinib)
b. Member experienced toxicity or intolerance to
prior therapy with a TKI
c. Member experienced resistance to prior therapy
with a TKI and results of BCR::ABL1 mutational
testing are negative for all of the following:
T315I/A, F317L/V/I/C, and V299L
2. Authorization of 12 months may be granted for members
who have received HSCT for Ph+ ALL/LL and results of
BCR::ABL1 mutation testing are negative for all of the
following: T315I/A, F317L/V/I/C, and V299L
C. Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted for treatment of
GIST when all of the following criteria are met:
1. Member has residual, unresectable,
recurrent/progressive, or metastatic/tumor rupture
disease
2. The disease harbors a platelet-derived growth factor
receptor alpha (PDGFRA) exon 18 mutation
3. Member has received prior therapy with avapritinib
4. The requested medication will be used as a single agent
D. Bone Cancer
Authorization of 12 months may be granted for treatment of
widespread metastatic chondrosarcoma or recurrent
chordoma when the requested medication is used as a single
agent.
E. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of
myeloid and/or lymphoid neoplasms with eosinophilia and
ABL1 rearrangement in the chronic phase or blast phase.
F. Cutaneous Melanoma
Authorization of 12 months may be granted for treatment of
cutaneous melanoma when all of the following criteria are
met:
1. The disease is metastatic or unresectable
2. The tumor has c-KIT activating mutations
3. The requested medication will be used as subsequent
therapy
4. Member has had disease progression, intolerance, or risk
of progression with BRAF-targeted therapy
5. The requested medication will be used as a single agent
IV. CONTINUATION OF THERAPY
A. CML
Authorization may be granted for continued treatment of CML
that has been confirmed by detection of Ph chromosome or
BCR::ABL gene by cytogenetic and/ or molecular testing
when either of the following criteria is met:
1. Authorization of 12 months may be granted when any of
the following criteria is met:
i. BCR::ABL1 is less than or equal to 10% and there is
no evidence of disease progression or unacceptable
toxicity while on the current regimen for members
who have been receiving the requested medication
for 6 months or greater
ii. Member has received HSCT and there is no evidence
of unacceptable toxicity or disease progression while
on the current regimen
2. Authorization of up to 7 months may be granted when the
member has completed less than 6 months of therapy
with the requested medication.
B. Acute Lymphoblastic Leukemia or Lymphoblastic
Lymphoma (ALL/LL)
Authorization of 12 months may be granted for continued
treatment of ALL/LL when there is no evidence of
unacceptable toxicity or disease progression while on the
current regimen and any of the following criteria is met:
1. Member has Ph+ ALL/LL that has been confirmed by
detection of Ph chromosome or BCR::ABL gene by
cytogenetic and/ or molecular testing.
2. Member has Ph-like B-ALL/LL with ABL-class kinase fusion
that has been confirmed by cytogenetic and/or molecular
testing.
3. Member has T-cell ALL/LL with ABL-class translocation
that has been confirmed by cytogenetic testing and/or
molecular testing.
4. Member has received HSCT for ALL/LL
C. GIST, Bone Cancer, Myeloid/Lymphoid Neoplasms with
Eosinophilia, or Cutaneous Melanoma
Authorization of 12 months may be granted for continued
treatment of GIST, chondrosarcoma, chordoma,
myeloid/lymphoid neoplasms with eosinophilia, or cutaneous
melanoma when there is no evidence of unacceptable toxicity
or disease progression while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Sprycel [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; February 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 17, 2023.
- NCCN Clinical Practice Guidelines in Oncology® Chronic Myeloid Leukemia (Version 2.2023). © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 17, 2023.
- NCCN Clinical Practice Guidelines in Oncology® Acute Lymphoblastic Leukemia (Version 1.2022). © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 17, 2023.
- NCCN Clinical Practice Guidelines in Oncology® Gastrointestinal Stromal Tumors (Version 1.2023). © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 17, 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
November 20, 2023
